Siemens Medical Solutions Recalls SOMATOM X.ceed Software Applications Over Lack of FDA Clearance

What Happened

Siemens Medical Solutions USA, Inc. has initiated a voluntary recall to remove specific software applications from certain SOMATOM X.ceed CT systems. The recall was triggered because the applications—syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS—were distributed without receiving the necessary FDA 510(k) clearance.

Which Products Are Affected

The recall affects two units of the SOMATOM X.ceed software applications. The specific identification details are as follows:

• Product Names: syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, syngo.CT ASPECTS
• Material Number: 11330002
• UDI-DI: 04056869231051
• Serial Numbers: 125205, 125250

The distribution of these units was worldwide, including the United States (nationwide), Canada, Costa Rica, India, and Israel.

What You Should Do

The firm initiated the recall process by sending notification letters to affected customers on December 19, 2025. Facilities using the SOMATOM X.ceed systems with the specified serial numbers should follow the instructions provided in the firm’s letter regarding the removal or disabling of the unauthorized software applications. For further information, users should contact Siemens Medical Solutions USA, Inc. directly.

Why This Matters

This recall is necessary to ensure that all medical software used in clinical settings has undergone the required regulatory review for safety and effectiveness. Using software that has not received FDA 510(k) clearance may pose unknown risks to patient diagnostic accuracy.

Source

This information is based on an official FDA Recall Notice under recall number Z-1239-2026.